Dexpramipexole and Warfarin Drug Drug Interaction (DDI) Study

Sponsor

Knopp Biosciences (Industry)

Overall Status

Completed

CT.gov ID

NCT01597310

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

7.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study will assess the effect of dexpramipexole on the pharmacokinetics (PK) of the CYP2C9 probe substrate warfarin in healthy volunteers.

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteers	Drug: Warfarin Drug: Dexpramipexole	Phase 1

Detailed Description

This is a single center open label study to assess the effect of Dexpramipexole on the PK of Warfarin in Healthy Volunteers. The goals of this study are as follows: to assess the effect of dexpramipexole on the pharmacodynamics (PD) of warfarin, to assess the safety and tolerability of dexpramipexole when administered alone, and with warfarin, and to assess the PK of dexpramipexole when administered alone; to explore the influence of genetic variation on the PK and international normalized ratio (INR) of warfarin when administered alone, and with dexpramipexole; and to explore the influence of genetic variation on the PK of dexpramipexole when administered alone.

Study Design

Study Type:

Interventional

Actual Enrollment :

15 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

An Open-Label Study to Assess the Effect of Dexpramipexole (BIIB050) on the Pharmacokinetics of Warfarin in Healthy Volunteers

Study Start Date :

May 1, 2012

Actual Primary Completion Date :

Jul 1, 2012

Actual Study Completion Date :

Jul 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Warfarin 25 mg Warfarin, Treatment Period 1 & Treatment Period 2	Drug: Warfarin single doses at specified time periods
Experimental: Dexpramipexole 150 mg BID Treatment Period 2	Drug: Dexpramipexole multiple doses

Arm

Intervention/Treatment

Experimental: Warfarin

25 mg Warfarin, Treatment Period 1 & Treatment Period 2

Drug: Warfarin

single doses at specified time periods

Experimental: Dexpramipexole

150 mg BID Treatment Period 2

Drug: Dexpramipexole

multiple doses

Outcome Measures

Primary Outcome Measures

Determination of the effect of dexpramipexole on the pharmacokinetics (PK) parameters of the CYP2C9 probe substrate warfarin including: AUC: area under the plasma-concentration time curve over a specified time period and Cmax: Maximum observed plasma c [pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 and 144 hours after warfarin administration in each dosing period]
PK parameters of dexpramipexole including but not limited to AUC: area under the plasma-concentration time curve over a specified time period and Cmax: Maximum observed plasma concentration [pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8 and 12 hours after administration of the morning dexpramipexole dose on Day 1 and Day 12 of Period 2]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Subjects who, in the opinion of the investigator, are healthy as determined by medical history, physical examination, and 12 Lead ECG.
Adult males/females aged 18 to 55 years inclusive.
Male and female subjects of childbearing age must practice effective contraception during the study and up to 90 days after their last dose of study drug.

Exclusion Criteria:

History of malignant disease, including solid tumors and hematologic malignancies.
Clinically significant current active infection or serious infection.
History of gastrointestinal bleeding, peptic ulcer disease, hemorrhoids or epistaxis.
Personal or family history of any bleeding disorder, and/or coagulation profile results outside of normal limits.
Known allergy or hypersensitivity to warfarin.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Research Site	Overland Park	Kansas	United States

Sponsors and Collaborators

Knopp Biosciences

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Knopp Biosciences

ClinicalTrials.gov Identifier:

NCT01597310

Other Study ID Numbers:

223HV105

First Posted:

May 14, 2012

Last Update Posted:

Nov 25, 2014

Last Verified:

Nov 1, 2014

Additional relevant MeSH terms:

Pramipexole

Warfarin

Study Results

No Results Posted as of Nov 25, 2014